MAUDE Adverse Event Report: LABSTYLE INNOVATIONS LTD DARIO BLOOD GLUCOSE MONITORING SYSTEM; GLUCOMETER

Model Number	1021-06
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On october 21st the user contacted dario to report high blood glucose (bg) readings.The user reported receiving from his dario meter bg readings that were consistently 14 mg/dl higher than his two other non-dario meters.The user stated that he tested all three meters with the same drop of blood.
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported that his two non-dario meters gave bg readings in the 88-90 mg/dl range, compared to a bg reading of 112 mg/dl from the user's dario meter.The user also stated that he first experienced this issue in september, when he first started using the dario meter.During this troubleshooting, it was determined that the user was using a cartridge of strips that was open for more than 30 days and was therefore expired.Dario's user guide states in the section precautions: "do not use a test strip expired 1 month from opening.Discard the cartridge 1 month after opening".The user was told that the results are within 15% of the ysi machine used in doctor offices at least 95% of the time and that it is normal to see a difference between devices as even the same drop of blood can yield different results.A replacement of dario's strips and control solution was sent to the user to make sure that the dario strips are reading correctly, and to ensure proper technique.After the above was received, multiple attempts to follow up with the user were made, however, no response has been received to date.The high bg readings may have been due to misuse of the strips.There is not enough information regarding the meter and old strips available to further investigate this case.Therefore, no resolution is available.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: GLUCOMETER
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD; 5 tarshish st; north industrial park; caesarea, 30798 21; IS 3079821
• Manufacturer Contact: 5 tarshish st; north industrial park; caesarea, 30798-21
• MDR Report Key: 23599114
• Report Number: 3010606081-2025-00099
• Device Sequence Number: 10380684
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1021-06
• Device Lot Number: 2110181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male